Altabax

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Local Irritation

In the event of sensitization or severe local irritation
from ALTABAX, usage should be discontinued, the ointment wiped off, and
appropriate alternative therapy for the infection instituted [see PATIENT INFORMATION].

Not for Systemic or Mucosal Use

ALTABAX is not intended for ingestion or for oral,
intranasal, ophthalmic, or intravaginal use. The efficacy and safety of ALTABAX
on mucosal surfaces have not been established. Epistaxis has been reported with
the use of ALTABAX on nasal mucosa.

Potential for Microbial Overgrowth

The use of antibiotics may promote the selection of
nonsusceptible organisms. Should superinfection occur during therapy,
appropriate measures should be taken.

Prescribing ALTABAX in the absence of a proven or
strongly suspected bacterial infection is unlikely to provide benefit to the
patient and increases the risk of the development of drug-resistant bacteria.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals to evaluate carcinogenic
potential have not been conducted with retapamulin.

Retapamulin showed no genotoxicity when evaluated in
vitro for gene mutation and/or chromosomal effects in the mouse lymphoma cell
assay, in cultured human peripheral blood lymphocytes, or when evaluated in
vivo in a rat micronucleus test.

No evidence of impaired fertility was found in male or
female rats given retapamulin 50, 150, or 450 mg/kg/day orally.

Use In Specific Populations

Pregnancy

Pregnancy Category B

Effects on embryo-fetal development were assessed in
pregnant rats given 50, 150, or 450 mg/kg/day by oral gavage on days 6 to 17
postcoitus. Maternal toxicity (decreased body weight gain and food consumption)
and developmental toxicity (decreased fetal body weight and delayed skeletal
ossification) were evident at doses ≥ 150 mg/kg/day. There were no
treatmentrelated malformations observed in fetal rats.

Retapamulin was given as a continuous intravenous
infusion to pregnant rabbits at dosages of 2.4, 7.2, or 24 mg/kg/day from day 7
to 19 of gestation. Maternal toxicity (decreased body weight gain, food
consumption, and abortions) was demonstrated at dosages ≥ 7.2 mg/kg/day
(8-fold the estimated maximum achievable human exposure, based on AUC, at 7.2
mg/kg/day). There was no treatment-related effect on embryo-fetal development.

There are no adequate and well-controlled studies in
pregnant women. Because animal reproduction studies are not always predictive
of human response, ALTABAX should be used in pregnancy only when the potential
benefits outweigh the potential risk.

Nursing Mothers

It is not known whether retapamulin is excreted in human
milk. Because many drugs are excreted in human milk, caution should be
exercised when ALTABAX is administered to a nursing woman. The safe use of
retapamulin during breast-feeding has not been established.

Pediatric Use

The safety and effectiveness of ALTABAX in the treatment
of impetigo have been established in pediatric patients 9 months to 17 years of
age. Use of ALTABAX in pediatric patients (9 months to 17 years of age) is
supported by evidence from adequate and wellcontrolled studies of ALTABAX in
which 588 pediatric patients received at least one dose of retapamulin
ointment, 1% [seeADVERSE REACTIONS, Clinical Studies]. The
magnitude of efficacy and the safety profile of ALTABAX in pediatric patients 9
months and older were similar to those in adults.

The safety and effectiveness of ALTABAX in pediatric
patients younger than 9 months of age have not been established. An open-label
clinical study of topical treatment with ALTABAX (twice daily for 5 days) was
conducted in patients 2 to 24 months of age. Plasma samples were obtained from
79 patients. In these pediatric patients, systemic exposure of retapamulin was
higher compared with patients 2 to 17 years of age. Furthermore, a higher proportion
of pediatric patients 2 to 9 months of age had measurable concentrations
( > 0.5 ng/mL) of retapamulin compared with patients 9 to 24 months of age [see
Pharmacokinetics]. The highest levels were seen in patients 2 to 6
months of age [see Pharmacokinetics]. The use of retapamulin is not
indicated in pediatric patients younger than 9 months of age.

Geriatric Use

Of the total number of patients in the adequate and
well-controlled studies of ALTABAX, 234 patients were 65 years of age and
older, of whom 114 patients were 75 years of age and older. No overall
differences in effectiveness or safety were observed between these patients and
younger adult patients.

Last reviewed on RxList: 1/28/2013
This monograph has been modified to include the generic and brand name in many instances.